Healthcare information must be accessed by developers, researchers, health care professionals, vendors, managers, insurers, and regulators, among others. The people accessing the information may have a diverse set of needs and resources and be distributed over a large geographic area. Numerous data systems may be required to interact to maintain all the required information and deliver it to the correct places at the proper times.
For managing healthcare information, current approaches include electronic data capture, large-scale databases of records, and automated systems to maintain and report the progress of the study. For compatibility between users and to comply with government requirements, such as for electronic reporting of clinical data to the FDA, extensible standards such as the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Modeling (ODM) standard are used to store and model clinical data. These standards allow vendors to extend the capability of a standard model to include additional information or functionality of value to the vendor's customers. The FDA requires access to such files, and their auditing benefits from the traceability and retrieval that such standards enable.
Projects in various healthcare areas have such data tracking & reporting requirements, including clinical studies, complaints about healthcare products, treatments, or drugs, managing patient records, etc. Problems may arise when different aspects of a project use incompatible data systems and information fails to be exchanged in an efficient manner, or at all, for example if a patient sees several specialists who all use different record-keeping systems. Patient records are collected by physicians and experts to keep track of the medical activity and status of a patient, and typically require the tracking of thousands of diverse pieces of information. Clinical trials to determine the safety and efficacy of new drugs, treatments or medical devices also typically require the tracking of such information, including not only patient records, but also experimental results, progress reports, and financial information. Complaints concerning healthcare products must be closely monitored and rapidly reported and addressed. Timeliness and completeness of a manufacturer's response to such complaints, and records about that response, is critical.
As used in this application, the term “healthcare information” refers to the results or data produced by or associated with any analysis, research, or data collection aimed at evaluating, reporting or claiming information that impacts the health state of a person. “Clinical trial” refers to any study, research, trial, or investigation of the medical efficacy or safety of a medical substance or device. “Patient records” refers to the results or data produced by or associated with any analysis, research, or data collection aimed at the current or past state of a patient in regards to the medical treatments or procedure he has been subject to.